A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis (EH20-357)
Aims: the purpose of this study is to compare the efficacy and safety of the study drug, fenebrutinib, to the FDA-approved medication teriflunomide (AUBAGIO) in adult patients with relapsing multiple sclerosis. Primary objectives include measure of time from baseline to fist occurrence of a progression event based on changes in EDSS score, increase in Timed 25-Foot Walk Test, increase in time to complete the 9-hole Peg Test and annualized relapse rate. The pharmacokinetics of fenebrutinib will also be evaluated. Eligible patients with relapsing multiple sclerosis will be randomly assigned to one of the two treatment arms at 1:1. Subjects who complete the initial 96-week-long double-blind treatment phase may be eligible to participate in a 96-week-long open-label fenebrutinib extension phase. Seven patients are expected to be enrolled at NorthShore sites.
Principal Investigator: Afif Hentati, MD
NorthShore Project Number: EH20-357
Contact: Call 847.503.4335 with questions regarding the study
Open to Enrollment: No
A Randomized, Open Label, Multi-Center, Active-Comparator Study to Assess the Efficacy, Safety and Tolerability of Ofatumumab 20mg SC Monthly Versus Continued Current Therapy in Relapsing-Remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)
Aims: The main purpose of this prospective research study is to investigate whether patients without a relapse in the past year would benefit from a switch to ofatumumab versus continued current therapy in a relapsing remitting MS population. The study will also look into whether a preceding elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch.
Principal Investigator: Carolyn Goldschmidt, DO
NorthShore Project Number: EH22-479
Contact: Call 847.503.4335 with questions regarding the study
Open to enrollment: Yes
Performance and Safety of a Digital Tool for the Unsupervised Self-Assessment of Neuromyelitis Optica Spectrum Disorder
Aims: The study product evaluated is NMOSDCopilot (version 1.0.0) designed and developed by the manufacturer Ad Scientiam. NMOSDCopilot is a Software as a Medical Device (SaMD) consisting of two different components: a mobile application for patients and a web dashboard for clinicians. The version used for this clinical study is an investigational device.
Principal Investigator: Afif Hentati, MD
NorthShore Project Number: EH23-131
Contact: Call 847.570.1864 with questions regarding the study
Open to enrollment: Yes